At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 3,301 enrolled
Drug / intervention
rLP2086 +1 morebiological
Likely dose
rLP2086 0.5 mLfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 3, Randomized, Placebo-controlled, Observer-blinded, Trial To Assess The Safety, Tolerability, And Immunogenicity Of Bivalent Rlp2086 Vaccine When Administered As A 3-dose Regimen In Healthy Young Adults Aged >=18 To <26 Years
In Brief
A Phase 3 clinical trial evaluating rLP2086 and Placebo for Healthy. Completed, enrolled 3,301 participants across 58 sites in 6 countries.
Detailed Summary
This study is looking at a new vaccine that might prevent meningococcal disease, and will study the immune response elicited by this vaccine when given to healthy young adults. The study will also look at the safety of the new vaccine as well as how it is tolerated.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesCanada, Denmark, Finland, Poland, Spain, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedMay 2011
Enrollment StartMay 2013
Primary CompletionFeb 2015
TodayJul 2026
First PostedMay 12, 2011
Enrollment StartMay 1, 2013
Primary CompletionFeb 1, 2015
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 15.1 years ago
Interventions
rLP2086biological
0.5 mL dose, given at 0, 2 and 6 months
Placeboother
0.5 mL dose, given at 0, 2 and 6 months